By Natalie O’Donnell, Executive Director, Safety, Epidemiology, Registries & Risk Management, UBC
A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance. This article answers the following questions regarding REMS
- How do you determine if a REMS is needed during product development?
- Who from your organization needs to be at the REMS design table?
- How do you align the products commercial strategy with the REMS?
- What are the appropriate metrics to assess your REMS?
- Can you implement a REMS in your organization or should you plan to outsource?